MYCOPHENOLATE MOFETIL- mycophenolate mofetil hydrochloride injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

MYCOPHENOLATE MOFETIL HYDROCHLORIDE (UNII: UXH81S8ZVB) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T)

Available from:

BPI Labs LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mycophenolate Mofetil [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)] , in combination with other immunosuppressants. Allergic reactions to Mycophenolate Mofetil have been observed; therefore, Mycophenolate Mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product. Mycophenolate Mofetil for Injection is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN). Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing Mycophenolate Mofetil treatment. To report a pregnancy or obtain inform

Product summary:

Mycophenolate mofetil (MMF) has demonstrated teratogenic effects in humans [see Warnings and Precautions (5.1)and Use in Specific Populations (8.1)] . Wearing disposable gloves is recommended during reconstitution and when wiping the outer surface of the bottle/cap and the table after reconstitution. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in Mycophenolate Mofetil for Injection USP (during or after preparation) [see Dosage and Administration (2.6)]. Follow applicable special handling and disposal procedure 1 . For injection: 500 mg mycophenolate mofetil as the hydrochloride salt in a 20 mL sterile single-dose vial cartons of 4 vials Cartons of 4 single-dose vials NDC 54288-141-04 Storage

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

                                SOLUTION
BPI Labs LLC
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MEDICATION GUIDE
Mycophenolate Mofetil for injection (mye” koe fen’ oh late moe’
fe til)
Read the Medication Guide that comes with Mycophenolate Mofetil before
you start taking it and each
time you refill your prescription. There may be new information. This
Medication Guide does not take
the place of talking with your doctor about your medical condition or
treatment.
What is the most important information I should know about
Mycophenolate Mofetil?
Mycophenolate Mofetil can cause serious side effects, including:
Increased risk of loss of a pregnancy (miscarriage) and higher risk of
birth defects.Females who take
Mycophenolate Mofetil during pregnancy have a higher risk of
miscarriage during the first 3 months
(first trimester), and a higher risk that their baby will be born with
birth defects.
•
If you are a female who can become pregnant, your doctor must talk
with you about acceptable
birth control methods (contraceptive counseling) to use while taking
Mycophenolate Mofetil. You
should have 1 pregnancy test immediately before starting Mycophenolate
Mofetil and another
pregnancy test 8 to 10 days later. Pregnancy tests should be repeated
during routine follow-up
visits with your doctor. Talk to your doctor about the results of all
of your pregnancy tests.
You must use acceptable birth control during your entire Mycophenolate
Mofetil treatment and
for 6 weeks after stopping Mycophenolate Mofetil, unless at any time
you choose to avoid sexual
intercourse (abstinence) with a man completely. Mycophenolate Mofetil
decreases blood levels of
the hormones in birth control pills that you take by mouth. Birth
control pills may not work as
well while you take Mycophenolate Mofetil, and you could become
pregnant. If you take birth
control pills while using Mycophenolate Mofetil you must also use
another form of birth control.
Talk to your doctor about other birth control methods that you can use
while taking
Mycophenolate Mofetil.
•
If you are a sexually active male whose female pa
                                
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Summary of Product characteristics

                                MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL HYDROCHLORIDE INJECTION,
POWDER, LYOPHILIZED, FOR SOLUTION
BPI LABS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MYCOPHENOLATE
MOFETIL FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
MYCOPHENOLATE MOFETIL FOR INJECTION.
MYCOPHENOLATE MOFETIL FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1995
WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES AND SERIOUS INFECTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
USE DURING PREGNANCY IS ASSOCIATED WITH INCREASED RISKS OF FIRST
TRIMESTER PREGNANCY
LOSS AND CONGENITAL MALFORMATIONS. AVOID IF SAFER TREATMENT OPTIONS
ARE AVAILABLE.
FEMALES OF REPRODUCTIVE POTENTIAL MUST BE COUNSELED REGARDING
PREGNANCY
PREVENTION AND PLANNING _[SEE WARNINGS AND PRECAUTIONS (5.1)]._
INCREASED RISK OF DEVELOPMENT OF LYMPHOMA AND OTHER MALIGNANCIES,
PARTICULARLY OF
THE SKIN _[SEE WARNINGS AND PRECAUTIONS (5.2)] _.
INCREASED SUSCEPTIBILITY TO INFECTIONS, INCLUDING OPPORTUNISTIC
INFECTIONS AND SEVERE
INFECTIONS WITH FATAL OUTCOMES _[SEE WARNINGS AND PRECAUTIONS (5.3)]._
RECENT MAJOR CHANGES
Indications and Usage, Pediatric Heart or Liver Transplants ( 1)
6/2022
Dosage and Administration, Dosage Recommendations for Heart Transplant
Patients
( 2.3)
6/2022
Dosage and Administration, Dosage Recommendations for Liver Transplant
Patients
( 2.4)
6/2022
Warnings and Precautions, Serious Infections ( 5.3)
10/2021
Warnings and Precautions, Acute Inflammatory Syndrome Associated with
Mycophenolate Products ( 5.7)
10/2021
INDICATIONS AND USAGE
Mycophenolate Mofetil is an antimetabolite immunosuppressant indicated
for the prophylaxis of organ
rejection in adult and pediatric recipients 3 months of age and older
of allogeneic kidney, heart or liver
transplants, in combination with other immunosuppressants. ( 1)
DOSAGE AND ADMINISTRATION
ADULTS
DOSAGE
Kidney Transplant
1 g twice daily, orally or intravenously (IV) over no
less than 2 h ( 2.2)

                                
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